编者按:“让天下没有难做的药,难治的病”,是初心,更是愿景。二十五年来,药明康德步履不停:从一间实验室,到覆盖亚洲、欧洲和北美的全球网络。从早期的化学合成服务,到贯穿研究(R)、开发(D)和生产(M)的一体化平台。从第一位客户,到全球三十多个国家的数千合作伙伴。不断发展的,是规模与能力;始终坚守的,是梦想与承诺。
致敬来时路,共谱新篇章!在二十五周年之际,我们以“逐梦者”视角,回顾药明康德成长发展的峥嵘岁月,回望赋能客户创新的并肩往事,更以独特的“药明精神”展望未来新篇章。
2017年春天,一声清脆的电话铃打破了理查德·索尔(Richard Soll)博士办公室的宁静。
没等第二声响起,索尔就接起了电话。电话那头传来一个豪放且富有磁性的声音,索尔对它再熟悉不过了。
“嗨,约翰,最近还好吗?”
“嗨,我的老朋友,呃……我想我需要你的帮助。”
声音的主人是约翰·胡德(John Hood)博士——他曾和索尔同在位于美国圣地亚哥的TargeGen公司共事。
多年前,两人可谓是一对黄金拍档,胡德是公司的研发总监,领导研发团队开发治疗癌症的小分子新药;索尔则是他的直属上司。
他们曾带领团队研发出多款小分子药物,在白血病和淋巴瘤等血液肿瘤中展现出了不俗的潜力。
其中一款叫做fedratinib的药物,更是在早期临床试验中就有惊艳的表现。它治疗的“骨髓纤维化”是一种罕见癌症,患者的骨髓干细胞会失控一样疯长,而fedratinib对这种疾病非常有效。
凭借这一突破性进展,TargeGen公司迅速受到行业关注,并于2010年以超6亿美元的交易额被一家知名药企并入麾下。
之后,这对黄金拍档功成身退。胡德共同成立了一家生物技术公司,出任首席科学官;索尔则加入药明康德,时任药物研发国际服务部高级副总裁。
再次听到老部下的声音,让索尔又回想起了曾经并肩奋战的黄金岁月。但胡德语气里流露出的些许紧张和不安,却又让索尔感到有些陌生。
短暂的叙旧过后,胡德说起了不安的原因。
在黎明到来之前
收购完成后,fedratinib的临床研发继续向更深入的阶段推进。
接下来的三年里,一共有877名患者在8项临床试验中接受了治疗。
和早期临床结果一致,这款创新药物再次缓解了骨髓纤维化患者的症状,给他们的生活带来了巨大的改变。
然而天不遂人愿。一些分析发现,有7位患者出现了较为罕见的不良症状,可能会导致大脑病变,甚至死亡。
图片来源:123RF
虽然没有搞清楚背后的原因,但安全起见,美国FDA为这些临床试验按下了“暂停键”。
这场突如其来的叫停,让一大批刚从病魔手掌中逃出的患者,重新陷入了“无药可用”的绝境。
特蕾莎·布兰达(Theresa Blanda)就是这批希望破灭的患者中的一员。
骨髓纤维化曾将她的生命推至悬崖边缘。在评估病情时,医生会根据严重程度,给不同患者打上一个0到4分的分数。
布兰达的得分是3分,距离病入膏肓只有一步之遥。
但fedratinib一度将她的病情降到了0分。在参加临床试验的5年时间里,布兰达眼看着自己的身体一天天好转,并开始畅想一个更美好的未来——她甚至打算和自己的高中恋人再续前缘,享受爱情的甜美。
然而临床试验的突然暂停,夺走了他们继续接受治疗的权利。
救命的药物“断供”后,布兰达和其他原本在临床试验中反应良好的患者的病情再度恶化,而其他治疗手段已经不再管用。
他们的医生纷纷前来恳求胡德,希望他作为药物的共同发明者,再想想办法。
胡德所在的生物技术公司与fedratinib并无关联。但作为一名新药研发者,每一款新药“都像自己的孩子一样”。他不忍心、也不甘心就此放弃。
更何况,在早些年的临床试验中,他亲自见证了这款药物如何能给患者的生命带来改变,也和一些患者建立了深厚的友谊,布兰达就是其中之一。
为了这款药物的生命,也是为了自己朋友的生命,他觉得无论如何还是该去争取一份希望。
对于像FDA这样的监管部门,“风险收益比”永远是他们的优先考量。如果患者不治疗就会死亡,即使有罕见的不良反应,也没那么令人难以接受了。
胡德说服FDA,对于那些明显可以从治疗中获益的患者,可以通过“同情用药”途径,继续治疗下去。
他在周五敲定了一切,并计划过完周末,在周一启动后续流程。
不久后,重获fedratinib治疗的患者们接连传来了好消息。其中一位患者说,她肿大的脾脏缩小了近50%、身体状况达到“近几十年来的最佳状态”。
然而,最初促使胡德推动此事的布兰达却再也没能等到这一天——就在万事俱备、曙光将至的那个周日,她已经永远地闭上了眼睛。
与有荣焉
早前,索尔也关注过这款命运曲折的新药,却没想到背后有如此令人唏嘘的往事。后来他特意去回看了相关报道,其中一篇这样写道:
布兰达生前的乐观坚强曾让研究团队深受感动,他们称赞她是“永不放弃的化身”。
一生乐于助人的她,就连患病后参加临床试验的初衷也是为帮助他人:“科学家和医生们帮助了我,我更要加倍努力,帮助更多患者。”
虽然这一回,布兰达没能坚持到最后,但她对美好生命的渴望至死不渝。
朋友的抱憾离去,深深刺痛了以救死扶伤为己任的胡德博士。多少次深夜梦回,他的内心始终无法平静——
于是,2016年秋天,在已知天命的年纪,在妻子的支持下,胡德掏出了自己的25万美元积蓄,毅然辞职创业,只为帮这款药“逆风翻盘”,帮更多患者延续生命。
正如他常挂在嘴边的那句话:
“当知道你的工作目标是拯救生命时,还有什么比这更有意义呢?”
听到这里,索尔已经大概猜到了胡德的来意。
他暗下决心,如果胡德需要自己所在团队为这款新药提供支持、改变更多患者的命运,他一定全力以赴。
胡德继续说着后半段的故事。2017年,他的新公司Impact Biomedicines经历了几轮融资,获得了fedratinib的开发权益,并以明确的证据表明,之前观察到的不良反应,和药物并无关联。
公司一切都在朝着好的方向发展,但这个发展速度却让胡德有些措手不及。为了一个关键时间节点,他需要大量的原料药。同时,为了更大程度地降低不良事件风险,产物的纯度也要足够高。
唯一的问题在于,留给药物规模化生产的时间有些不多了。
除非,可以找到一个经验丰富,又熟悉这个项目的团队?
在他的脑海里,立即蹦出一家公司的名字——药明康德。
所以有了开头他打给索尔的那通电话。
“50公斤原料药,6个月内就要完成,你们能做吗?”
电话那头,胡德深吸了一口气,语气中透露出无限担忧。
关于生产周期,他已经做过功课,多数CXO公司给出的答案都在12-14个月。
但为了与一家大型制药公司达成协议,他们当下只有6个月的时间窗口。
这意味着,药明康德需要用行业平均水平2倍的速度来完成整个生产过程。
诚然,他跟索尔已是相熟多年的前同事,这款新药也是他们共同参与过的原研药物;
诚然,业内以经验丰富著称的药明康德早已用无数次真实案例证明,“药明速度”不是空话。
但这个远超业内平均水平的高难度要求,还是让他有些开不了口。
他甚至不敢细想,如果药明康德也做不了,其他公司能做的可能性还有多大?
自己刚创立的公司资金周转困难倒是其次。真正受到伤害的,还是那群让他心心念念的、再次进入生命倒计时的患者们。
索尔非常理解胡德的忧虑。他见过太多新药跌宕起伏的命运,也有时仅一步之差,就能决定一款药物的成败。
这一次,药明康德一如既往地回应了客户的需求,没有让胡德失望。
这一次,索尔带领的药明康德科学家团队,再度与胡德成为并肩作战的战友。
4个多月后,订单交付的结果又一次刷新了胡德博士对“药明速度”的认知:
——交付重量不止50公斤,而是达到了69公斤;
——交付时间也更早,甚至比原计划提前了一个多月,而且“纯度非常高”!
索尔坦言,在过去,类似这样的需求大概需要耗时更久;但到了2018年,药明康德化学业务平台的能力已经比之前上了几个台阶。
改变这一切的,不是惊天动地的科学发现,而是一次又一次静默无声的技术升级,是不断拓宽的研发和生产规模,以及各个团队、各个员工之间专业、严谨与紧密的协作。
2019年,fedratinib获FDA批准上市。
图片来源:123RF
在短短2年内,这款新药就实现了从项目启动到被大型药企收购、最终成功获批上市的神速跨越,打赢了这场精彩的“逆风局”。
对此,索尔和药明康德的科学家们也为助推了这次进程感到与有荣焉。
很多人说,胡德博士是英雄。
但不管是演讲还是采访中,胡德博士都劝大家不要叫他“英雄”。
他认为,英雄是患者们,或是推动、支持这一行动的其他人。比如他曾对索尔表示“药明康德在这个案例中是一个真正的英雄”。
但最重要的,是胡德的勇气、毅力和对新药的信念,才将这款救命药带给了患者。
如今,怀着“及时发现更多救命药”的愿景,胡德又踏上了新的创业旅程,并继续与药明康德开展长期合作。
“那我先试一年”
而对索尔而言,当公司收获众多客户赞誉的那一刻,当公司赋能的新药成功上市、来到患者身边的那一刻,就是让他成就感满满的高光时刻。
这一切,还要归于他在17年前的一次“尝试”。
想当初,在接到药明康德的邀请前,索尔作为资深的药物化学专家,已在医药行业深耕25年、曾担任美国多家生物技术公司高管。
但那段时间,他一度特别煎熬。
那是2008年,也是全球生物医药产业经历残酷寒冬的一年。
在离开TargeGen,职业生涯的下一步尚不明确时,药明康德向他抛来了橄榄枝:
“要不,你来药明康德做药物化学研究吧?”
那段时间,他也有过犹疑:
——化学领域的医药研发赋能服务还处于早期阶段,真能做成吗?
——从一家研发特定领域新药的生物技术公司,转而投身一家在各个领域、各个阶段助力众多客户做大量新药的CXO公司,未来的路该怎么走?他能适应这个改变吗?
但吸引他的因素显然更多。
作为药明康德最早的一批客户之一,他对第一次合作时的场景还记忆犹新。
图片来源:123RF
那是21世纪初,索尔博士作为3-Dimensional公司的化学副总裁,想请药明康德做一个基于“组合化学与高通量筛选”技术的化合物库。
当时,组合化学还是一项新兴技术——通过高通量筛选,让分子们进行各种组合、反应,从而打造出庞大、多样的化合物库,再从中分离出可能有价值的“种子选手”。
这个过程有点像买彩票,把各种分子像数字一样随机组合,然后期待未知的幸运降临;
但同时,这个过程又依赖于工业化的严谨流程,每个步骤需要精细推演,容不得半点差池。
让他颇感意外的是,药明康德的早期团队当即决定投资昂贵的设备来支持这一需求。
事后回想,他的嘴角仍忍不住上扬:“(当时)我甚至还没签合同。”
在后来的多年合作中,他已经见证了药明康德以客户为中心的高质量服务、准时交付和快速成长,也见证了创始人团队过人的远见、魄力与胆识,双方因此建立了长期的信任关系。
所以对于药明康德的邀请,他并不意外。
“好,那我先试一年。”
或许在旁人看来,他的回答依旧“信心不足”,但这是他作为科学家的严谨和负责。不管是好是坏,尽力了就不会有遗憾。
而连他自己都没有想到,这一“试”,就是将近20年。
这17年来,陆续又有多名成就斐然的高管加入药明康德。在管理团队的带领下,药明康德化学业务平台的能力不断发展壮大,如今已成长为一个能力全面的CRDMO平台,一个能“为合作伙伴新药开发过程中的各个阶段提供服务、满足不同规模业务需求、涵盖各种合成分子形式”的平台。
截至2025年第三季度的一组数据显示,该平台正同时支持着3430个小分子创新药的工艺研发及生产,其中包括87个临床3期和80个商业化阶段的化学药物。
享受这份低调
谈到加入公司后的收获与感触,索尔表示:
“在药明康德的这些年来,我有幸遇到了很多正在创业的科学家,还有许许多多的业务同事,他们杰出的成就与优秀的品质也让我受益匪浅。
依靠药明康德的CRDMO平台,我得以持续赋能客户、造福广大患者,追随着公司‘让天下没有难做的药、难治的病’的愿景砥砺前行。这让我感到非常荣幸。”
这段发自肺腑的话,正如索尔的一贯作风——低调、谦逊。
本周,儿童肿瘤基金会(CTF)为索尔颁发了一个奖项,以表彰他为“根除神经纤维瘤病(NF)”的使命做出的重大贡献。当被问及关于获奖的感想,他却说:
“其实,其他获奖者为攻克NF所做的贡献都比我大多了。我只是做了一点微不足道的工作,却得以和他们共此殊荣。对此,我感到很荣幸,也很谦卑”。
每当有新药横空出世、造福患者时,人们的目光常常聚焦在那些闪亮登场的新药和它们的开发团队,而常常忽视为其提供赋能服务的“幕后工作者”。
但索尔非常享受这份低调,享受着在药明康德作为“幕后工作者”的一员——既能支持众多合作伙伴将新药理念变为现实,更能帮助无数患者摆脱病痛、破茧重生。
他知道,就像胡德的那通电话那样,只要合作伙伴有需要,药明康德总会挺身而出,从未缺席。
The Second Yes: A Cancer Drug’s Second Life
Editor’s Note: “Every drug can be made and every disease can be treated”. Over the past 25 years, from a single laboratory to a global network spanning Asia, Europe, and North America; from early chemical synthesis services to an integrated platform that connects Research (R), Development (D), and Manufacturing (M); from its very first customer to thousands of partners across more than 30 countries, WuXi AppTec has never stopped moving forward to realize its enduring vision.
In tribute to the journey and in celebration of new beginnings, we look back through the eyes of our “dream-makers”: revisiting the stories of partnership that empowered global innovation, and the unique spirit that continues to guide us toward the next chapter.
Years ago, Richard Soll saw two photos of a child with neurofibromatosis type 1 (NF1), a rare disease that causes tumors to grow on nerves. In the first, taken before the child enrolled in a clinical trial, a large lump swelled on his neck. In the second, after treatment with selumetinib, the tumor was nearly invisible.
“It was remarkable to me,” Soll says. “It sent a strong message that we must continue efforts to find more effective drugs that can be used across all forms of life.”
As Senior Advisor for Strategic Initiatives at WuXi AppTec, Soll devoted himself to the Children’s Tumor Foundation (CTF, a driving force in NF research), serving on its Board of Directors and helping elevate global awareness. At the company, he championed rare-disease initiatives, ensuring NF received attention on the world stage. Under his leadership,WuXi AppTec hosted an NF-focused webinar that drew participants from 22 countries, a milestone that helped expand knowledge in regions where the condition remains little known.
On Monday, Soll received the Cloud Carrier Award from CTF for his visionary leadership, global impact on drug discovery, and heartfelt dedication to the NF community. To him, it is simply another example of how he supports the development of innovative medicines so they can reach patients with the most urgent needs.
The Beginning
In the early 2000s, Soll was Vice President of Chemistry at 3-Dimensional Pharmaceuticals. Combinatorial chemistry, an emerging technology at the time, had the odds of a lottery and the rigor of a factory: build vast, diverse libraries for high-throughput screening and pray the numbers hid a hit.
He had heard about a contract research start-up named WuXi AppTec. Soll contacted the company, asking if they could build a unique library for him. Unlike the prevailing combinatorial chemistry business models at the time, WuXi AppTec put no financial constraints on the design or scale of the libraries which were exclusively for 3-Dimensional. Further to Soll’s surprise,one of the founders would invest in expensive equipment required to do it right. “I hadn’t even signed a contract.”
Source:123RF
That collaboration made 3-Dimensional one of the first biotech customers of WuXi AppTec, and the work came back with “very good quality” and formed the foundation of what became a multi-decade long collaborative partnership between Soll and WuXi AppTec where trust,customer-oriented service, and on-time delivery never faded.
When Soll moved to TargeGen, a San Diego-based biotech company, as CSO and head of R&D, he made the kind of call that seems obvious in retrospect today, but heretical at the time: outsource the medicinal chemistry analog work (hit-to-lead and lead optimization) to WuXi AppTec along with scale-up for preclinical evaluation. At the time, over two decades ago, outsourcing to this extent was an outlier. Most firms preferred to keep this kind of work in-house.
To ensure the quality, Soll flew over and evaluated in detail the labs and facilities, the people, indeed the system.It was part of the process that later was embodied in WuXi AppTec’s “3P principle”: prevention, protection, prosecution.
Out of that collaboration came a clinical candidate, TG-101348. Years later, the strength and depth of relationship would resurface with John Hood, head of TargeGen’s oncology, who brought back to life the once-shelved asset, a life-saving drug for myeloproliferative disorders.
The Resurrection
Theresa Blanda was 57, an accountant with a rare blood cancer that turned bruises into omens and fatigue into a way of life. On the disease’s scale of 0 to 4, she was a 3.
Then she joined a clinical trial, became one of the first patients to receive TG-101348. That drug turned everything around, and moved her back to zero.
Due to the potential, TargeGen was acquired in a deal worth up to $635 million, with its compound TG-101348, later known as fedratinib.
Then, in a late-stage trial, the researchers found a rare side effect among few patients, triggered a regulatory hold. That means patients who had gotten better on the drug no longer have access to it.
Their physicians pleaded in vain to keep the drug available. Other treatments were not helpful. Without the drug, Blanda declined quickly, and ultimately relapsed.
Then they came to Hood, the scientist who co-invented TG-101348 and helped set up the clinical trial, to see if he can do anything.
Hood and Blanda’s physician negotiated a compassionate-use exemption for patients like her. The approval arrived one Friday with logistics to be finalized on Monday.
Blanda died that Sunday.
If there is a scene that explains why people like Hood stay in the arena after the first company sale, it is that one. “I felt an obligation, indeed a moral duty, to continue the quest to get this beneficial drug to the patients.” Hood said.
Endorsed by his wife, Hood left his job and established a company called Impact Biomedicines to continue the work. Hood put in $250,000 of his own money to start.
The “Yes”
Impact obtained rights to the drug, confirmed the side effect was not related to fedratinib treatment, and lifted the clinical hold.
After regulators signaled that the data on hand was sufficient to support a filing, buyers gathered. On the opening day of the 2018 J.P. Morgan healthcare conference, Celgene announced a $1.1 billion upfront acquisition, a fifty-fold return on Impact’s thirteen-month-old Series A.
Everything moved at a velocity people call “good problems to have.” Hood’s problem was that good companies can still run out of time. He needed commercial-grade bulk drug substance for pivotal studies and with the kind of purity that doesn’t trigger a new obstacle at scale. He needed a partner who already had familiarity and experience with this program, so he called Soll.
“50 kilos in six months,” Hood said, already prepared for the lecture about cycle times and vendor capacity; a typical answer would be twelve to fourteen months, with caveats.The team delivered not 50 kilos, but 69 and one month ahead of schedule and, as Hood would later say, “with spectacular purity.”In 2019, the drug was approved.
“WuXi AppTec was a real hero in this case,” Hood told Soll afterward. But it was John, whose courage, perseverance and belief in fedratinib brought this life-saving drug to patients.
Source:123RF
Today, John Hood uses WuXi AppTec across a multitude of companies he has founded in the hope that other life-saving drugs will be found in a timely manner.
The Commitment
To Soll, the compliment justified why he worked for WuXi AppTec for 17 years.
“I said I’ll only try this for one year.” He laughed, recalling his first days.
“But WuXi AppTec really lived up to its commitment. There's no better place that I would put my hands on.”
“At WuXi AppTec I have had the good fortune of meeting many worthy entrepreneurial scientists and business colleagues over the years; it is incredibly inspiring to see the fruits of these efforts and the life-saving impact they have on patients. It has been a distinct honor to represent our company in our visionary quest through the WuXi AppTec CRDMO platform: “Every drug can be made and every disease can be treated.”
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